Fast-Cath™ 406136Recalls & reported problems
St. Jude Medical, Inc. · Class 2
Quick summary
This St. Jude Medical Fast-Cath introducer sheath is used to guide catheters and guidewires into blood vessels during procedures. The 44 reports mostly describe blood or fluid leaking around the sheath or its valve, sometimes with side ports that would not lock, and a few mention blood loss during the procedure. There are 3 injuries and 1 death reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 44
- Deaths reported
- 1
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05414734014137), received between Jan 22, 2019 and Dec 17, 2025 — classified as 1 death, 3 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (42 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak42
- Use of Device Problem2
- Gas/Air Leak1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- No Consequences Or Impact To Patient8
- Hemorrhage/Blood Loss/Bleeding5
- Blood Loss1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING A PROCEDURE, AFTER INSERTING THE GUIDEWIRE, THE SHEATH WAS NOTED TO BE LEAKING AROUND THE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825161 ↗InjuryDec 2, 2025Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem
DURING THE COARCTATION STENT PROCEDURE, BLOOD WAS OBSERVED TO LEAK FROM THE SEAL. THE SHEATH WAS REPLACED BUT THE SAME ISSUE OCCURRED. THE SECOND SHEATH WAS REPLACED, BUT THE SAME ISSUE OCCURRED AGAIN. A SMALLER SHEATH WAS PLACED WITHIN THE BIGGER SHEATH FOR HEMOSTASIS, BUT THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS WHICH REQUIRED VOLUME INFUSION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23692375 ↗MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PLACEMENT, RIGHT INTERNAL JUGULAR VEIN ACCESS VESSEL PROCEDURE. THE SHEATH WAS INSERTED INTO THE VESSEL AND WHEN A GUIDEWIRE WAS INSERTED ACROSS THE VALVE OF THE SHEATH, BLOOD WAS NOTED TO BE LEAKING FROM THE VALVE. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DEVICE. THE SHEATH WAS EXCHANGED, AND AGAIN BLOOD LEAKED WHEN A 0.035 GUIDEWIRE WAS INSERTED. THE LEAK OCCURRED ONLY WHEN THE GUIDEWIRE WAS INSERTED. THE SECOND SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321904 ↗MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE PATIENT UNDERWENT A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PLACEMENT, RIGHT INTERNAL JUGULAR VEIN ACCESS VESSEL PROCEDURE. THE SHEATH WAS INSERTED INTO THE VESSEL AND WHEN A GUIDEWIRE WAS INSERTED ACROSS THE VALVE OF THE SHEATH, BLOOD WAS NOTED TO BE LEAKING FROM THE VALVE. THERE WAS NO PHYSICAL DAMAGE NOTED ON THE DEVICE. THE SHEATH WAS EXCHANGED, AND AGAIN BLOOD LEAKED WHEN A 0.035 GUIDEWIRE WAS INSERTED. THE LEAK OCCURRED ONLY WHEN THE GUIDEWIRE WAS INSERTED. THE SECOND SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320839 ↗MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH SIDE PORT WAS BLEEDING BACK AND WOULD NOT LOCK. THE SHEATH WAS EXCHANGED BUT THE SAME ISSUE OCCURRED. A DIFFERENT SIZE SHEATH WAS THEN USED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928686 ↗MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH SIDE PORT WAS BLEEDING BACK AND WOULD NOT LOCK. THE SHEATH WAS EXCHANGED BUT THE SAME ISSUE OCCURRED. A DIFFERENT SIZE SHEATH WAS THEN USED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928605 ↗MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE, THE HEMOSTASIS VALVES OF THE SHEATH WAS LEAKING BLOOD. UPON INSPECTION IT WAS FOUND THAT THERE WAS NO SEAL ON THE SHEATH. THE SHEATH WAS EXCHANGED TO RESOLVE THE ISSUE WITHOUT ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068722 ↗MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE, THE HEMOSTASIS VALVES OF THE SHEATH WAS LEAKING BLOOD. UPON INSPECTION IT WAS FOUND THAT THERE WAS NO SEAL ON THE SHEATH. THE SHEATH WAS EXCHANGED TO RESOLVE THE ISSUE WITHOUT ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21068667 ↗MalfunctionMar 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION CRYO PROCEDURE THE HEMOSTASIS VALVE WAS LEAKING BLOOD. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984024 ↗DeathMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PROCEDURE, BLEEDING WAS NOTED FROM THE HEMOSTASIS VALVE WHEN THE INTRODUCER WAS PLACED IN THE FEMORAL COMMON ARTERY. A NON ABBOTT INTRODUCER WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18846677 ↗MalfunctionOct 23, 2023Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURE REF: 3005334138-2023-00487. DURING THE PROCEDURE, A LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF 2 SHEATHS. A 3RD SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17985938 ↗MalfunctionJun 15, 2023Use of Device Problem; Use of Device Problem
AN EXPIRED PRODUCT WAS INSERTED INTO THE PATIENT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17134794 ↗MalfunctionJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURING REF: (B)(4). UPON REMOVAL OF THE HEMOSTASIS INTRODUCER, THE VALVE TO THE INTRODUCER DID NOT SEAL CLOSE AS EXPECTED WHICH ALLOWED BLEEDING FROM THE INTRODUCER. THE HEMOSTASIS INTRODUCER WAS IMMEDIATELY EXCHANGED FOR A SECOND INTRODUCER OF THE SAME MODEL AND LOT. THE SECOND INTRODUCER VALVE WOULD NOT SEAL EITHER, ALLOWING FOR BLEEDING. THE SECOND SHEATH WAS THEN EXCHANGED FOR A NON ABBOTT INTRODUCER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17118433 ↗MalfunctionMar 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION CRYOABLATION PROCEDURE, A BLOOD LEAK FROM THE HEMOSTASIS VALVE WAS NOTED. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16629090 ↗MalfunctionFeb 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURING REFERENCE: 3005334138-2023-00053. DURING AN ATRIAL FIBRILLATION CRYOBALLOON ABLATION PROCEDURE, IT WAS NOTED THAT THE HEMOSTASIS VALVE OF THE INTRODUCER WAS LEAKING BLOOD. THE DEVICE WAS EXCHANGED FOR ANOTHER INTRODUCER OF THE SAME MODEL AND LOT # BUT THE SAME ISSUE WAS NOTED. THE DEVICE WAS EXCHANGED AGAIN TO AN INTRODUCER WITH THE SAME MODEL BUT DIFFERENT LOT # AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364657 ↗MalfunctionFeb 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURING REFERENCE: 3005334138-2023-00054. DURING AN ATRIAL FIBRILLATION CRYOBALLOON ABLATION PROCEDURE, IT WAS NOTED THAT THE HEMOSTASIS VALVE OF THE INTRODUCER WAS LEAKING BLOOD. THE DEVICE WAS EXCHANGED FOR ANOTHER INTRODUCER OF THE SAME MODEL AND LOT # BUT THE SAME ISSUE WAS NOTED. THE DEVICE WAS EXCHANGED AGAIN TO AN INTRODUCER WITH THE SAME MODEL BUT DIFFERENT LOT # AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364591 ↗MalfunctionFeb 12, 2023Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak
DURING AN ATRIAL FIBRILLATION CRYO ABLATION PROCEDURE, THE HEMOSTASIS VALVE WAS LEAKING BLOOD. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16359943 ↗MalfunctionJan 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A BLOOD LEAK WAS NOTED AT THE HEMOSTASIS VALVE AFTER REMOVAL OF THE DILATOR. THE DEVICE WAS NOT REPLACED, MORE BLOOD WAS NOTED THAN IF THE VALVE FUNCTIONED PROPERLY. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16263219 ↗MalfunctionJan 30, 2023Fluid/Blood Leak; Fluid/Blood Leak
DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A BLOOD LEAK WAS NOTED AT THE HEMOSTASIS VALVE AFTER REMOVAL OF THE DILATOR. THE DEVICE WAS NOT REPLACED, MORE BLOOD WAS NOTED THAN IF THE VALVE FUNCTIONED PROPERLY. THERE WERE NO CONSEQUENCES TO THE PATIENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16263206 ↗MalfunctionDec 6, 2022Fluid/Blood Leak; Fluid/Blood Leak
DURING A CRYO PROCEDURE, A BLOOD LEAK WAS NOTED AT THE HEMOSTASIS VALVE. ANOTHER SHEATH FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15925419 ↗MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURING REF: 3005334138-2022-00598. DURING THE PROCEDURE, TWO LEAKS WERE NOTED AT THE HEMOSTASIS VALVES. DURING INTRODUCTION OF THE NON ABBOTT TRANSSEPTAL SYSTEM (BAYLIS), LEAKS WERE NOTED WITH 2 SHEATHS. FOLLOWING TRANSSEPTAL ACCESS, THE PROCEDURE WAS COMPLETED WITH A NON ABBOTT CATHETER (MEDTRONIC FLEXCATH) WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15709552 ↗MalfunctionNov 1, 2022Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURING REF: 3005334138-2022-00599. DURING THE PROCEDURE, TWO LEAKS WERE NOTED AT THE HEMOSTASIS VALVES. DURING INTRODUCTION OF THE NON ABBOTT TRANSSEPTAL SYSTEM (BAYLIS), LEAKS WERE NOTED WITH 2 SHEATHS. FOLLOWING TRANSSEPTAL ACCESS, THE PROCEDURE WAS COMPLETED WITH A NON ABBOTT CATHETER (MEDTRONIC FLEXCATH) WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15709549 ↗MalfunctionJul 21, 2022Fluid/Blood Leak; Fluid/Blood Leak
DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A BLOOD LEAK OCCURRED WHEN THE .0.38" WIRE AND 6F PIGTAIL CATHETER WERE PLACED THROUGH SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15074209 ↗MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PROCEDURE, A BLOOD LEAK OCCURRED FROM THE HEMOSTASIS VALVE. THE DEVICE WAS REPLACED IN ORDER TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13600737 ↗MalfunctionJan 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
RELATED MANUFACTURER REF: 3005334138-2022-00026. DURING THE PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE DEVICE WAS EXCHANGED AND THE ISSUE REOCCURRED. THE PROCEDURE WAS COMPLETED USING A THIRD INTRODUCER WITH NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13357689 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.